Lubricated trocar valve

ABSTRACT

A sealing arrangement for trocar tubes including an upper ring seal forming the primary seal, and a lower seal valve forming the secondary seal. Both seals form part of a valve system which can be positioned within a removable cartridge. The valve cartridge comprises a tubular open-ended housing in which the seal ring is fitted to the top opening, and with the seal valve located within the housing. The seal valve is elastomeric in tubular form for passing instruments and is provided with upper and lower flanges for placement within the cartridge. The intermediate portion of the valve between the flanges is in the general form of converging and diverging frusto-conical sections which join along a sealing line. A seal is formed between the interior wall surfaces of the valve and the instrument present in the trocar tube. Peritoneal pressure is admitted to the trocar head or housing for pressing the valve in forming the desired seal. With the instrument removed, the valve walls engage each other along the seal line to form the desired seal. The valve walls are layered with hydrogel and a microencapsulated liquid coating substantially extending the shelf-life of the valve, providing lubricity for the valve surface, and improving the sealing characteristic of the base elastomer of the valve body.

BACKGROUND OF THE INVENTION

The present invention relates to surgical instruments and particularlyto an improved seal arrangement for a trocar tube.

A conventional trocar assembly comprises two basic interfitting,separable components: a trocar obturator subassembly and a trocar tubesubassembly. The trocar obturator subassembly includes a supporting headwith an elongate obturator having a tip. The tip can be a blunt orsharpened cutting tip and the tip is sometimes provided with aprotective shield. The trocar tube includes a head and a depending tubetogether with a sealing arrangement within the head for closing andsealing the tube when it is in position during surgery. The assemblyincludes the trocar obturator interfitting the trocar tube with the tipprojecting from the end of the tube and, if desired, being covered bythe protective shield.

In ordinary use the trocar assembly penetrates a body cavity and thetrocar obturator subassembly is withdrawn leaving the trocar tube inplace for introducing other instruments into the body according to therequirements of a particular medical procedure. The trocar tube isprovided with a sealing arrangement to close the tube in order tomaintain the gas pressure within the body cavity as required for themedical procedure.

My U.S. Pat. No. 5,242,412 discloses a seal for a trocar assembly, andin the Background of the Invention, the patent describes conventionalsealing arrangements for trocar tubes.

The primary task of a trocar seal is to maintain pneumoperitonealpressure while an operating instrument is present in the trocar tube,while the instrument is being inserted or removed, and after removal. Insome cases the trocar double seal within the trocar tube includes anupper seal in the form of a sealing ring and a lower sealing valve.

Surgical instruments pass through the upper and lower seals giving riseto the hazard of the instrument injuring or disturbing the propersealing position of one of the seals particularly the lower seal withinthe trocar tube housing. This hazard is present in the cases ofdisposable as well as non-disposable trocar tubes. Non-disposable trocartubes are intended for reuse after sterilization and the opportunityarises for gradual weakening and ultimate failure of the lower seal byreason of exposure to repeated passing of surgical instruments.

The present invention provides an improved sealing arrangement fortrocars in order to guard against seal failure due to instrumentmanipulation through the trocar, and to provide a seal cartridge thatcan be replaced periodically or after each use of the trocar for asingle surgical procedure.

The present invention provides an inexpensive sealing arrangement fortrocars with no moving parts in either of the upper and lower seals.This results in low manufacturing cost and feasibility of disposabletrocar designs.

The invention also provides for improving the operating characteristicsof the valve particularly its ready-to-use capability without the needto prehydrate before use, as well as valve surface lubricity and sealingcharacteristics.

SUMMARY OF THE INVENTION

The present invention comprises a sealing arrangement for trocar tubesincluding an upper ring seal forming the primary seal, and a lower sealvalve forming the secondary seal.

In a preferred form of the invention, both seals form part of a valvecartridge. The valve cartridge is removable from the trocar tube and canbe replaced as desired for reuse of the trocar tube. The valve cartridgecomprises a tubular open-ended housing in which the seal ring is fittedto the top opening, and with the seal valve located within the housing.The seal valve is preferably elastomeric and tubular in form for passinginstruments and is provided with upper and lower flanges for placementwithin the cartridge. The intermediate portion of the valve between theflanges is in the general form of converging and divergingfrusto-conical sections or panels which come into contact with eachother along a sealing line. A seal is formed by contacting interior wallsurfaces of the valve before an instrument enters the trocar tube.Peritoneal pressure is admitted to the trocar head or housing forpressing the valve walls together in forming the desired seal.

When an instrument is introduced into the trocar tube, the upper ringseal engages the periphery of the instrument to maintain the desiredperitoneal pressure within the trocar tube.

The valve cartridge is vented within the trocar housing to admitperitoneal pressure to the seal valve exterior.

The lower or diverging frusto-conical portion of the valve maintains thesealing integrity of the valve by preventing instrument snags thatdisturb the proper sealing position of the seal valve as instruments areremoved from the trocar tube.

The sealing arrangement further includes an insert positioned within theseal valve in axial alignment with the valve passage to protect thevalve wall interior surfaces from injury or puncture as an instrumentpasses in and out of the trocar tube. The insert protects the side wallswithout interfering with their normal sealing function.

In another preferred form of the invention, the sealing arrangement fortrocar tubes including the upper ring seal forming the primary seal, andthe lower seal valve forming the secondary seal are built into thetrocar tube so that the entire trocar tube can be discarded after asingle use.

In another aspect of the invention, the surfaces of the primary seal andthe interior surface of the lower seal valve are coated with a hydrogellayer which, when hydrated as by absorbtion of water, fluffs up andbecomes very slippery, i.e., provides a lubricious surface. Thehydrating liquid absorbed by hydrogel gradually evaporates therebydepriving the hydrogel of its desired lubricious surface and severelylimiting the shelf life of the product.

In accordance with the invention, the hydrogel layer is preferablyapplied to the elastomeric substrate in a dry or non-hydrated conditionand the hydrogel layer is then covered with a microencapsulated liquidsuitable for hydrating the hydrogel. The microencapsulated liquidremains dormant and the hydrogel in dry (i.e., non-hydrated) conditionuntil the liquid is released from microencapsulation when themicrocapsules are ruptured by an impinging object such as an instrumentpassing through the primary seal or lower seal valve interior. When themicroencapsulated cells are ruptured, the contained liquid is releasedto activate the hydrogel coating thereby providing the desired slipperysurface condition on the base material of the seal surfaces.

In this way, the microencapsulated liquid coating for the hydrogellayered valve substantially extends the shelf life of the trocar,provides lubricity for the seal surfaces precisely at the moment ofneed, and improves the sealing characteristic of the base elastomer ofthe valve body.

OBJECTS OF THE INVENTION

It is an object of the invention to provide a primary and secondarysealing arrangement for a trocar tube.

It is an object of the invention to provide a low cost primary andsecondary sealing arrangement for a trocar tube.

It is an object of the invention to provide a seal cartridge for atrocar tube.

It is a further object of the invention to provide a seal valve for atrocar tube which resists deformation and loss of sealing integrityinduced by instruments passing through the valve.

It is a further object of the invention to provide a protective insertfor trocar seal valves.

It is a further object of the invention to provide a disposable trocartube.

It is another object of the invention to provide hydrogel layered sealsfor trocar tubes wherein, by hydrating the hydrogel, the lubricity andsealing characteristics of the trocar are improved.

It is a further object of the invention to provide a microencapsulatedliquid coating for a hydrogel layered valve to achieve a valve that isready-to-use even after extended shelf life, to provide lubricity forthe valve surface, and to improve the sealing characteristic of the baseelastomer of the valve body.

Other and further objects of the invention will occur to one skilled inthe art with an understanding of the following detailed description ofthe invention or upon employment of the invention in practice.

DESCRIPTION OF THE DRAWING

A preferred embodiment of the invention has been chosen for purposes ofillustrating the construction and operation of the invention and isshown in the accompanying drawing in which:

FIG. 1 is a perspective view of an assembled trocar.

FIG. 2 is an exploded perspective view of the components of the trocarof FIG. 1.

FIG. 3 is a vertical section view of the valve cartridge shown in FIG.2.

FIG. 4 is a perspective view of the primary and secondary seal membersfor use in a trocar tube.

FIG. 5 is a vertical section view of the seal members of FIG. 3.

FIG. 6 is a vertical section view of the seal members of FIG. 5 with aninstrument passing through the trocar tube.

FIG. 7 is a perspective view of a cartridge insert.

FIG. 8 is a modified form of the cartridge and primary and secondaryseals.

FIG. 9 is a schematic illustration of a sealing surface substrate coatedwith a hydrogel layer and with a microencapsulated liquid for hydratingthe hydrogel.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIGS. 1 and 2 of the drawing, an assembled trocar 10according to the invention comprises a trocar obturator 12, a trocartube 14, and a valve cartridge 16.

The trocar obturator comprises a head 12a, an elongate shaft 12bextending downwardly from the head and terminating in a trocar tip 12c.

The trocar tube includes an upper shell or housing 18 and a dependingtube 20 through which pass the trocar obturator and surgical instruments(not shown) for endoscopic surgery. The housing has a port 22 (which maybe fitted with a stop cock 24) used for insufflating and desufflating anabdominal cavity, for example, through the trocar tube. The upper shellis shown cylindrical in shape, however, it can be any suitable shape,box-like for example. The shell has an opening 26 at its upper end andhas an internally threaded flange 28 or other suitable fastening meansto receive and secure the valve cartridge 16 according to the invention.

The cartridge comprises an upper collar 30 and a depending cylindricalskirt 32 for receiving and positioning primary 34 and secondary seals 36(FIG. 4) and the protective insert 38 (FIGS. 3 & 7) for the secondaryseal, for attachment to the shell, for defining a sealed axial passagefor the trocar as well as instruments passed through the trocar tube,and for admitting peritoneal pressure to the exterior surfaces of thesecondary seal.

The exterior and interior elements of the cartridge assembly are shownin FIGS. 2 and 3 and include cap or collar 30 and subjacent threadedsection 33 for securing the cartridge to the trocar shell. The remainingskirt portion 32 of the cartridge is long enough to cover entirely thesecondary seal valve while having vents 35 for the purpose of admittingperitoneal pressure to the exterior surface 40 of the secondary seal.The vents are preferably in the form of slits extending upward from thebottom edge 37 of the skirt best shown in FIG. 2, it being understoodthat other shaped openings in the skirt may be used for venting.

The interior surface of the cartridge has inwardly extending concentricledges or rims 42a, 42b and 42c for supporting the primary and secondaryseals.

A modified form of the cartridge and primary and secondary seals isshown in FIG. 8 in which the primary 44a and secondary 44b seals are aone piece molding 44 supported by inwardly extending rims 36a and 36b. Aprotective insert 38 shown also in FIG. 8 may be fitted inside themolding 44 for protecting the secondary seal 44b in a manner similar toprotection of the embodiment of FIG. 3.

The primary seal 34 is positioned on the upper ledge 42c of thecartridge. The primary seal includes a peripheral rim 34a which may beof square cross-section, and a radially extending annular sealing web34b having a central aperture 34c of a diameter less than that of thetrocar shaft and instruments passing through the trocar tube. As shownin FIG. 6, the elastic or elastomeric web 34c deflects and engages thetrocar shaft 12b in a sealing relationship for maintaining peritonealpressure within the trocar tube when the trocar shaft or an instrumentis present.

The secondary seal 36 is preferably elastomeric and is positioned onintermediate and lower interior ledges 42a and 42b of the cartridgeskirt which respectively support upper and lower peripheral rims orflanges 36a and 36b of the secondary valve. The valve rims are joined bya generally cylindrical air tight tube 36c. The intermediate tubeportion of the valve between the flanges is in the general form ofconverging 36d and 36e and diverging 36f and 36g planar wall sectionswhich join along a sealing line 36h (FIG. 5). Beginning at oppositesides of the tube just below the upper flange, the tube walls 36d and36e on each side are planar with opposite upper planar walls convergingdownwardly toward ther seal line 36h defined by touching interiorsurfaces of the planar wall sections.

Beginning at the seal line, the lower opposite planar side walls 36f and36g diverge outwardly and downwardly from the upper planar wallsrejoining the tubular wall just above the lower flange. The lower planarwalls comprise return panels which protect the integrity of the sealline by resisting the tendency of instruments to disturb the seal lineby inverting the upper planar walls when passing through the seal valve.The secondary seal is a one-piece molded elastomeric valve which is airtight with a wall thickness sufficient to withstand and maintainperitoneal overpressure within the trocar shell.

The valve cartridge further includes a protective insert 38 of rigidlightweight plastic having a peripheral rim 38a and a dependingtruncated skirt 38b. The insert is placed within the seal valve on aledge 36i formed therein with its protective skirt protecting thesidewalls of the valve against puncture, and acting as a guide fordirecting the trocar shaft and instruments with sharp tips to passaxially through the trocar tube and seal without puncturing the seal.

In another aspect of the invention, the valve and sealing ring arepreferably elastomeric and provided with a hydrogel coating that absorbswater and makes the valve and ring very slippery in order to enhancetheir resistance to cutting or puncture by a passing trocar shaft orinstrument.

Referring to FIG. 9, an elastomeric substance 50 such as polyurethane,silicone, latex, nitrile, thermoplastic elastomer or a host of othersimilar materials may be used for fabricating the valve and sealingring. The interior surface 50a of the valve or ring is coated with ahydrogel layer 52 which, when hydrated as by absorbtion of water, fluffsup and becomes very slippery, i.e., provides a lubricious surface. Inaccordance with the invention, the hydrogel layer is preferably appliedto the elastomeric substrate in a dry or non-hydrated condition. Theouter surface 52a of the hydrogel layer is then covered with amicroencapsulated liquid 54 suitable for hydrating the hydrogel. Themicroencapsulated liquid remains dormant and the hydrogel in dry (i.e.,non-hydrated) condition until the liquid is released frommicroencapsulation. The microencapsulated liquid is any suitable liquidfor hydration of the hydrogel such as water, saline solution, alcoholand so forth.

The period of dormancy extends from time of manufacture until the trocaremploying the valve is placed in service. When a trocar shaft orinstrument moving through the central passage of the trocar strikes thevalve interior surface or sealing ring, the microcapsules are rupturedimmediately releasing liquid in quantity sufficient to hydrate thehydrogel resulting in a lubricious valve surface for passing theinstrument without puncturing or marring the sealing surface.

It is to be noted in particular that the instrument or trocar shaftstrikes the valve walls in the vicinity of the sealing line 36h therebyreleasing liquid for hydrating the hydrogel surface along the sealingline to improve the sealing characteristic of the base valve material.

In this way, the microencapsulated liquid coating for the hydrogellayered valve provides a ready-to-use trocar even after elapse of a longshelf life of the trocar. With the microencapsulated liquid coating, itis not necessary for the surgeon to independently hydrate the hydrogelimmediately prior to use. The microencapsulated coating provideslubricity for the valve surface precisely at the moment of need, andimproves the sealing characteristic of the base elastomer of the valvebody.

I claim:
 1. An elastomeric sealing valve for a trocar comprising upperand lower peripheral rims joined by a generally cylindrical air tighttube, the tube portion of the valve between the rims being in thegeneral form of upper converging and lower diverging planar wallsections which meet along a diametric sealing line defined by touchinginterior surfaces of the planar wall sections the lower planar wallscomprising return panels which protect the integrity of the seal line byresisting the tendency of instruments to disturb the seal line byinverting the upper planar walls when passing through the seal valve,the interior surface having a layer of non-hydrated hydrogel thereon,and a coating of microcapsules containing a liquid covering the hydrogellayer for releasing the liquid to hydrate the hydrogel when themicrocapsules are ruptured.
 2. An elastomeric sealing valve for a trocarcomprising upper and lower peripheral rims joined by a generallycylindrical air tight tube, the tube portion of the valve between therims having wall sections which meet along a sealing line defined bytouching interior surfaces of the planar wall sections, the interiorsurface of the valve having a layer of non-hydrated hydrogel thereon,and a coating of microcapsules containing a liquid covering the hydrogellayer for releasing the liquid to hydrate the hydrogel when themicrocapsules are ruptured.
 3. A trocar tube for receiving trocarobturators and surgical instruments, the trocar tube comprising ahousing in the form of a hollow shell with aligned first and secondopenings in opposite sides of the housing defining a central passagetherethrough, the first opening being in the top side of the shell, thesecond opening being in the bottom side and having a tube affixedthereto, the tube having an axis aligned with the central passage, aprimary seal positioned in the housing around the first opening andencompassing the central passage, a secondary seal positioned in thehousing to encompass the central passage, the secondary seal havingupper and lower peripheral rims joined by a generally cylindrical airtight tube, the tube portion of the valve between the rims being in thegeneral form of upper converging and lower diverging planar wallsections which meet along a diametric sealing line defined by touchinginterior surfaces of the planar wall sections the lower planar wallscomprising return planar walls which protect the integrity of the sealline by resisting the tendency of instruments to disturb the seal lineby inverting the upper planar walls when passing through the seal valve,the interior surface of the valve having a layer of non-hydratedhydrogel thereon, and a coating of microcapsules containing a hydratingliquid covering the hydrogel layer for releasing the liquid to hydratethe hydrogel when the microcapsules are ruptured thereby to lubricatethe interior surface and to improve the sealing chararacteristic of thevalve along the seal line.
 4. A trocar tube for receiving trocarobturators and surgical instruments, the trocar tube comprising ahousing in the form of a hollow shell with aligned first and secondopenings in opposite sides of the housing defining a central passagetherethrough, the first opening being in the top side of the shell, thesecond opening being in the bottom side and having a tube affixedthereto, the tube having an axis aligned with the central passage, aprimary seal positioned in the housing around the first opening andencompassing the central passage, the surface of the primary sealencompassing the central passage having hydrogel thereon, a secondaryseal positioned in the housing to encompass the central passage, thesecondary seal having upper and lower peripheral rims joined by agenerally cylindrical air tight tube, the tube portion of the valvebetween the rims being in the general form of upper converging and lowerdiverging planar wall sections which meet along a diametric sealing linedefined by touching interior surfaces of the planar wall sections thelower planar walls comprising return planar walls which protect theintegrity of the seal line by resisting the tendency of instruments todisturb the seal line by inverting the upper planar walls when passingthrough the seal valve, the interior surface of the valve havingnon-hydrated hydrogel thereon, and a coating of microcapsules containinga hydrating liquid covering the hydrogel of the primary and secondaryseals for releasing the liquid to hydrate the hydrogel when themicrocapsules are ruptured thereby to lubricate the primary andsecondary seals.